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Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

NCT00357903 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 639

Last updated 2017-02-09

Study results available
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Summary

This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.

Conditions

Interventions

BIOLOGICAL

Etanercept

Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).

Sponsors & Collaborators

  • Immunex Corporation

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-04-30
Primary Completion
2008-12-31
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357903 on ClinicalTrials.gov